Diagnostic performance of fecal Helicobacter pylori antigen test in Uganda

Abstract We evaluated the diagnostic performance of a qualitative stool antigen test (SAT) in individuals with dyspepsia in rural Uganda using the polymerase chain reaction-based 16S ribosomal RNA assay (16S rRNA) for nucleotide sequences for two common H. pylori -associated genes as the reference standard. We enrolled 150 adults with dyspepsia with no self-reported use of antibiotic and/or antiacid medication medications within a fortnight. We performed blinded SAT on fecal specimens and 16S rRNA tests on gastric specimens. Using nonlinear mixed models, SAT had a sensitivity of 85⋅1% (95%CI 76⋅54%, 93⋅6%), and specificity of 97⋅6% (95%CI 94⋅3, 100). Twelve individuals with dyspepsia need to be tested to correctly diagnose 10 with H. pylori infection using SAT. The SAT is a robust diagnostic test to improve the diagnosis of H. pylori infection in people with dyspepsia in resource-limited settings.